Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer

A pioneering biotech company was advancing a next-generation antibody–drug conjugate (ADC) aimed at treating non-small cell lung cancer (NSCLC) — the most prevalent form of lung cancer and a condition where therapeutic options remain limited. While the team initially planned a U.S.–only, first-in-human (FIH) dose-escalation study, rapidly shifting market pressures and new regulatory expectations, including heightened scrutiny under the FDA’s Project Optimus, required a strategic change in course.

Facing increasing competition and the need for a more globally scalable and scientifically rigorous development plan, the Sponsor recognized that success hinged on partnering with a CRO capable of more than standard early-phase execution. They needed a global organization with the agility to manage a complex FIH program, the scientific and operational depth to navigate ADC-specific safety considerations, and a demonstrated ability to design and operationalize trials aligned with Project Optimus principles.